JIT · Class II · 21 CFR 862.1150

FDA Product Code JIT: Calibrator, Secondary

Leading manufacturers include Dade Behring, Inc., Wako Chemicals USA, Inc. and E.I. Dupont DE Nemours & Co., Inc..

245
Total
245
Cleared
59d
Avg days
1976
Since
245 devices
49–72 of 245
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789
Siemens Healthcare Diagnostics, Inc.
Chemistry · 77d
Cleared Sep 03, 2008
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10
K082141
Biokit, S.A.
Chemistry · 35d
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319
Siemens Healthcare Diagnostics, Inc.
Chemistry · 84d
Cleared Jul 07, 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683
Siemens Healthcare Diagnostics
Chemistry · 20d
Cleared Mar 19, 2008
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545
K080166
Beckman Coulter, Inc.
Chemistry · 56d
Cleared Dec 12, 2007
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210
K072717
Dade Behring, Inc.
Chemistry · 78d
Cleared Aug 08, 2007
MISSION OLYMPUS AU ISE CALIBRATORS
K071039
Diamond Diagnostics, Inc.
Chemistry · 118d
Cleared Apr 30, 2007
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
K070552
Dade Behring, Inc.
Immunology · 62d
Cleared Mar 16, 2007
OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
K062521
Thermo-Electron Corp.
Chemistry · 200d
Cleared Feb 01, 2007
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS
K070144
Beckman Coulter, Inc.
Chemistry · 16d
Cleared Aug 24, 2006
ABX PENTRA 400: LIPOPROTEINS
K060854
Horiba Abx
Chemistry · 148d
Cleared Aug 16, 2006
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27
K062152
Dade Behring, Inc.
Chemistry · 20d
Cleared Aug 14, 2006
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250
K061885
Dade Behring, Inc.
Chemistry · 42d
Cleared Jul 18, 2006
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
K061818
Dade Behring, Inc.
Chemistry · 20d
Cleared Jul 13, 2006
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
K061751
Dade Behring, Inc.
Chemistry · 22d
Cleared Jul 10, 2006
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
K061702
Dade Behring, Inc.
Chemistry · 24d
Cleared Jul 06, 2006
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K061139
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jun 02, 2006
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585
K061282
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Apr 24, 2006
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
K060140
Diagnostic Chemicals , Ltd.
Chemistry · 95d
Cleared Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
K060754
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Apr 14, 2006
ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
K060359
Denka Seiken Co., Ltd.
Chemistry · 60d
Cleared Mar 21, 2006
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
K060322
Cliniqa Corporation
Chemistry · 40d
Cleared Mar 13, 2006
FERRITIN CALIBRATOR SET, CATALOG NO. 8203
K053291
Reference Diagnostics, Inc.
Chemistry · 108d
Cleared Mar 09, 2006
THE EMIT 2000 TACROLIMUS CALIBRATORS
K060371
Dade Behring, Inc.
Chemistry · 24d